The present invention relates to an intracardiac suture device for use in treatment of intracardiac defects by suturing the defective portion with a suture needle.
For treatment of intracardiac defects such as atrial septal defect, ventricular septal defect and valvular disease, it is general practice to perform surgical operations with an artificial heart-lung machine (i.e., an extracorporeal circulation system). The heart-lung machine is a device, which performs hemoperfusion instead of the heart of a patient during the stopped period of the pumping action of the heart and acts the breathing function for the lung by prosecution of the gas exchange in the blood. The heart-lung machine generally comprises four main components, i.e., a blood pump, an oxygenator, a heat exchanger and a reservoir. The heart-lung machines have been used widely as auxiliary measures for extracorporeal circulation in open-heart surgery. Further, they have also been used as auxiliary measures for supplementary circulation when any bad circulation of the internal organ and/or organization arises from considerable decrease in the pumping action of the heart, or auxiliary measures for gas exchange when the function of the patient's lung is considerably damaged. In addition, the lung-heart machines are used in membrane oxygenator-assisted extracorporeal circulation (ECMO), and as auxiliary measures for extracorporeal circulation in thoracic aortic aneurysm surgery.
In the first era of cardiac surgery, surgical operations of pulsating hearts have been carried out blindly by the feel and thus the safety has come up as a serious problem before development of an artificial heart-lung machine. In 1953, Dr. Gibbon succeeded in a first cardiac surgery with an artificial heart-lung machine. From that time, the safety of the cardiac surgery has been improved by various improvements in heart-lung machines and development of myocardial depressants. Now, the use of extracorporeal circulation makes it possible to perform the cardiac surgery safely.
However, even at the present state of the art, the cardiac surgeries with the heart-lung machines are at risk for the following postoperative complications:
(1) Complication in the brain: Cerebral hypoxemia or cerebral edema resulting from incorrect perfusion. Cerebral infarction due to embolization by of tissue fragments into the blood caused by interfusion of intake-air into extracorporeal circulation in the heart-lung machine or by operation to connect the heart-lung machine to the patient;
(2) Complication in the lung: hypoxemia or ventilatory insufficiency caused by various inflammatory substances, which are activated by the heart-lung machine;
(3) Renal dysfunction: Acute renal failure caused by decrease in renal blood flow due to use of the heart-lung machine;
(4) Blood cell injuries: Blood cell injuries are taken place by performing perfusion of the blood into the artificial, i.e., heart-lung machine. This may cause renal dysfunction, resulting in necessity of blood infusion;
(5) Postoperative bleeding: Postoperative bleeding may occur by the disorder of the in-vivo hemostatic function caused by the heart-lung machine;
(6) Aortic dissection: By insertion of an arterial inflow cannula into the aorta, the endothelium of the blood vessel may be injured and induced the acute aortic dissection. This complication is extremely serious condition and death rate of a patient is high;
(7) Other complications: Postoperative infective diseases and multiple organ failure caused by decrease of immunoreaction.
It is often the case that these complications cause systemic inflammation even if the patient's condition is not severe and the length of postoperative stay in the hospital takes one week at the least. Further, the artificial circulation passage used in operation is of disposable, a high medical cost presents problems for the patients.
Recently, a tendency to avoid the side effects due to use of the artificial hear-lung is seen in the field of coronary artery bypass, and operations without use of the artificial hear-lung machine have been popularized. In particularly, minimally invasive surgery employing an endoscope is widely used and has become of major interest lately because of low occurrence of complications and rapid recovery after operation.
Even in the field of cardiac surgery, there is an increasing demand for intracardiac surgeries which can be performed without use of any hear-lung machine. It is however, impossible to stop the beat of the heart. Further, it is pointed out that there would be considerable difficulty in use of the endoscope since the blood and beating heart obstructs the view from the endoscope. Commercially available catheter devices such as “Amplatzer” (brand name), “Angelwing” (brand name) are applied for treatment of atrial septal defects. These devices are designed for uniformly distributed defects as targets. Thus, it is difficult with such devices to treat the intracardiac defects since these defects vary with the individual patient. For these reasons, there is a great demand for any breakthrough for realizing cardiac surgery without use of any artificial heart-lung machine.